Devices and related methods for targeted pressure and temperature therapies for pelvic region disorders and syndromes

ABSTRACT

Disclosed herein are devices and related methods for using those devices in the relieving and/or treating of pain, discomfort, and/or inflammation in the pelvic region using targeted pressure and temperature delivery. The devices and methods for using those devices to deliver targeted pressure and temperature therapy internally to patients through their rectal or vaginal cavities are disclosed.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 11/475,996, filed Jun. 28, 2006, now U.S. Pat. No. 7,695,489,filed Jun. 28, 2006, which application in turn claims the benefit ofU.S. Provisional Patent Application Ser. No. 60/694,792, filed Jun. 28,2005.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates, in general, to devices and relatedmethods for using those devices in the relieving and/or treating ofpain, discomfort, and/or inflammation in the pelvic region usingtargeted pressure and temperature delivery. More particularly, thepresent invention relates to devices and methods for using those devicesto deliver targeted pressure and temperature therapy internally topatients within their rectal or vaginal cavities.

2. Relevant Background

Many people suffer from pelvic floor dysfunction, painful bladdersyndrome, vulvodynia and other non-infectious pelvic syndromes thatcause them to experience pain or discomfort with intercourse, urination,defecation, or other physical activities. In some cases, pain anddiscomfort symptoms can occur sporadically or chronically without theparticular suffering person being readily able to identify activities aspotential causes for the symptoms. There is much speculation andresearch in the medical community that such non-infectious pelvicsyndromes may be at least partially caused by muscles in the pelvic area(and the “pelvic floor” muscles in particular) that are too tight,strained or cramping. This is believed to cause these muscles to spasmor even to bear upon or pinch sensitive nerve bundles in the pelvicarea, causing combinations of localized, generalized and referred painand discomfort sensations.

In situations where strengthening or relaxing of the pelvic floormuscles or drug therapy does not resolve the patient's pelvic issuesover time, surgical approaches are sometimes tried. For example, U.S.Pat. No. 6,862,480 describes a surgery entailing implanting a device fortreating pelvic disorder that comprises an electronic implant, whichincludes a sensor, a microchip, and electrostimulator. The implant isadapted to sense muscle spasms and apply electrical stimulation throughone or more electrodes to treat the disorder. As appropriate, thecontrol unit may configure the current applied by the electrodes so asto treat various pelvic dysfunction related disorders, such as stressincontinence, fecal incontinence, interstitial cystitis, urineretention, or other sources of pelvic pain or discomfort. The use of theimplant described in this patent, however, requires the patient toundergo a painful surgery, thus limiting its attractiveness and usesignificantly.

In situations where more traditional physical therapy or drug therapiesdo not resolve the patient's pelvic condition or disorder, there is adesire for medical providers to have exhausted all conservativetreatment approaches before invasive therapies, such as surgerydescribed in U.S. Pat. No. 6,862,480, are tried. In this regard, thereis much recent research regarding so-called “trigger-points” and “tenderpoints” for the cause of pain and discomfort. Myofascial tissue (alsocalled “fascia”) wraps around muscle tissue, muscle fibers, bundles offibers, and the muscles themselves, and then continues on to formtendons and ligaments. When muscular dysfunction is present, musclescontract, or cramp, to varying degrees, which is known as “going intospasm.” Ordinary muscle cramps and contractions release with movement,that is, stretching of the affected musculature. When the muscle islocked into a deep and painful spasm, it is said to form a “triggerpoint” or “tender point.” These points do not release with stretching.Instead, they are locked into a strong state of contraction. Thiscontraction is essentially a localized hardening of the muscle tissueand associated fascia.

To the touch, trigger and tender points feel like hardened knots in theotherwise softer surrounding tissue. Trigger points and tender pointsare generally distinguished from one another semantically in that theyare classified as trigger points if they “refer” pain or discomfortsensations to other parts of the body or alternatively as tender pointsif they only cause localized pain or discomfort. Trigger points locatedin the pelvic floor muscles, due to the various nerve bundles located inthat region, can cause referred pain to the bladder, urethra, vagina,vulva, testicles, rectum, and other areas of the pelvic region. When amuscle develops a trigger point (e.g., goes into spasm), it can compressor pinch different nerves, thereby sending messages of pain or otherdiscomfort to the brain. Since nerves can pass through many muscles,sometimes the pain is “felt” in a muscle other than the originatingsite, causing a referred pain situation. Trigger points in particularare now widely speculated to cause referred pain for a variety ofmedical conditions, disorders, and syndromes causing or otherwiseassociated with pelvic pain, discomfort, or dysfunction.

As appreciation of the trigger point theory of pain and discomfortgrows, many medical professionals are beginning to prescribe physicaltherapy sessions to treat or resolve trigger and tender points, inaddition to or instead of drug and surgical therapies, as part of aregimen for treating various non-infectious pelvic syndromes andsymptoms of pain, discomfort, or inflammation in the pelvic region.Myofascial trigger point therapy is one such physical therapy technique.It involves the systematic application of pressure to tender muscles andmyofascial tissue in order to relieve pain, discomfort, and othersymptoms of dysfunction with the goal of returning the muscles andfascia to their normal, relaxed states.

Myofascial trigger point therapy is a massage-type physical therapytechnique that releases “trigger points” in the muscles in the pelvis orother areas. Trigger point therapy is the application of sustained,direct pressure onto a trigger point. In practice, this direct pressureis often repeatedly applied, and at different angles, to an identifiedtrigger point. One theory regarding the mechanism of action is that theapplied pressure interrupts various neural signals that cause one ormore of the spasm and/or the pain. In any event, such pressure has beenfound to ultimately lengthen the muscle into its normal state and breakspasm-pain-spasm cycles that cause referred and/or localized pain. Italso enables the myofascial tissue to release any constriction, andreturn to its normal state, preventing further spasms.

In the particular case of utilizing myofascial trigger point therapy forthe treatment of pelvic region syndromes and disorders, it is the casethat many of the suspect pelvic floor muscles are most directly or mosteasily accessed internally. Given the difficulty of accessing internaltrigger points in the pelvic floor muscles, the patients are oftenreferred by their health care provider to a physical therapist that isspecially trained to do internal myofascial trigger point releasetherapy. Oftentimes, such therapists will require the patient to performexercises or follow-up therapies at home. Problems arise, however, whena particular patient does not have available a partner to assist in thehome therapy. Anatomical limitations prevent such patients from beingable to manually access the trigger points at home without anappropriately adapted treatment tool. Conventionally available tools,however, are not well suited for such purposes.

Many conventional physical therapy devices suitable for home use by apatient and designed for the pelvic region are particularly designed forgeneral strengthening of the pelvic floor muscles (such as forincontinence or constipation), and not for providing targeted internaltherapy such as trigger point therapy. For example, the performance ofexercises to strengthen and/or retrain the pelvic floor muscles (e.g.,Kegel exercises) can be augmented with various commercially availableintra-vaginal and/or intra-anal devices adapted to facilitate or improvethe performance of the pelvic exercises. Such intra-vaginal and/orintra-anal devices have included weighted apparatus such asintra-vaginal cones. Patients are instructed to insert the weighted andtapered cone into the vagina or rectum and squeeze their pelvic musclesin order to retain the device for a certain length of time. Other typesof prior art devices include electromyographic (EMG) transducers orsensors which are insertable into or placed just outside of the vaginaand/or anus to obtain EMG data indicative of baseline pelvic floormuscle tone and/or contraction(s) of the pelvic floor muscles during theperformance of specific muscle contraction exercises. Such EMG data maybe usable for diagnostic purposes as well as for monitoring theperformance and/or effect of muscle training exercises. Thus, suchconventional devices available on the market designed for home use inpelvic floor physical therapy are unsuitable for internal pelvic triggerpoint therapy.

Furthermore, it is conventional in many areas of medicine to usetemperature therapies, including hot (thermal) and cold (cryogenic)packs or baths, to battle symptoms of pain and discomfort. Heat and coldcan be used alternatively and are often used as a prelude to exercise orphysical therapy.

Heat therapy in particular is known to induce vasodilation and assist indrawing blood into the target tissues. The increased blood flow deliversneeded oxygen and nutrients, and removes cell wastes. Heat is also knownto decrease muscle spasms, relax tense muscles, relieve pain, andincrease range of motion. There are available many devices andmechanisms to provide thermal therapy, including a variety of commercialhot packs, hot water bottles, hot towels/compresses, electrical moistheat devices, disposable self-heating patches, hot baths andhydrocollators. These conventional devices and mechanisms, however, aredirected to provide generalized heat therapy by application to the skin,making them largely ineffective in the targeted therapy of the pelvicregion with thermal therapy.

Conversely, cold therapy produces vasoconstriction, which slowscirculation and reduces inflammation, muscle spasm, and pain. Cryogenictherapy devices are available in many forms including a variety ofcommercial cold packs, ice cubes, iced towels/compresses, and forms ofhydrotherapy. Like with conventional thermal therapy devices andmechanisms, conventional cryogenic therapy devices and mechanisms arenot suitable for providing targeted temperature therapy in the pelvicregion.

There are several devices that are commercially available for providingcryotherapy at and just inside the anus for hemorrhoid relief. Forexample, U.S. Pat. No. 5,800,485 describes a system that uses afinger-shaped projection for insertion into the rectum. The projectionis cooled by a cold fluid (such as cold water) that circulates throughchannels within the projection, thus providing generalized cooling tothe surrounding tissue. The system uses an electrical pump to circulatethe cooling fluid. The projection used in this system is relativelyshort and has substantially the same diameter over its length due to itsfunction of treating swelling around the anal opening. The design of theprojection thus make this system incapable of reaching deeply into thevaginal or rectal cavities of the patient and manipulated to delivertargeted pressure or temperature therapy at particular treatment points.Further, the system of this patent is fairly complicated, requiring theuser to provide a cooling fluid and power (batteries or an electricaloutlet) for the pump.

Similarly, the cryotherapy device marketed under the trade name“Hemor˜Rite” by FAMA Holdings International Corp. of Coral Springs,Fla., is adapted for applying cold therapy directly to the swollenhemorrhoidal veins to provide temporary relief of itching, pain, andswelling. The device comprises a traffic-cone shaped device that isfilled with a ice-pack material that can be frozen in the freezer. Thecone shaped device, once frozen, is directed for insertion into therectum to deliver cold therapy generally in and around the area of theanus. The device is similar in shape to vaginal cones used for pelvicmuscle exercising, having a substantial taper with its base beingsubstantially larger in diameter than the distal end that pushes intothe cavity. This shape makes the Hemo˜Rite device incapable of reachingdeeply into the vaginal or rectal cavities of the patient to delivertargeted pressure or temperature therapy.

Thus, there remains a need for improved devices and related methods forusing those devices in the relieving and/or treating of pain,discomfort, and/or inflammation in the pelvic region using targetedpressure and temperature therapy.

SUMMARY OF THE INVENTION

It is an object of some aspects of the present invention to provideimproved devices and methods for relieving pelvic pain, discomfort,inflammation, and other symptoms associated with pelvic regionsyndromes, disorders, conditions and diseases.

Also, it is an object of certain aspects of the present invention toprovide novel treatment devices and methods for using those devices thatcan be easily and efficiently self administered by a person experiencingsymptoms in the pelvic region, including pain or discomfort, at the timethat the pain or discomfort is being experienced, thus obviating theneed to schedule a treatment appointment with a therapist.

Also, it is also an object of certain aspects of the present inventionto provide a novel device that is composed of material that enhancessafety and sterility of the device, operates easily and effectively forproviding targeted temperature therapy to internal tissues, and operatessafety to reduce the risk of injuries due to misuse duringself-administration of therapy.

The present invention provides devices and related methods for treatingwith targeted pressure and temperature therapy inflammatory andnon-infectious vaginal, vulvar, anal and/or pelvic pain syndromes, andsymptoms associated with or resulting from one or more vaginal or rectaldiseases, conditions, disorders, or conditions.

The methods according to the present invention treat such syndromes andsymptoms by using devices according to one or more embodiments of thepresent invention to provide one or more of targeted thermal temperaturetherapy, targeted cryogenic temperature therapy, and target pressuretherapy internally via the vaginal or rectal cavities to one or moretreatment sites within the pelvic region.

For example, according to embodiments of the present invention, one mayreduce inflammation in the pelvic region by using devices according toembodiments of the invention to provide targeted cryogenic (i.e., cold)therapy via the vaginal cavity. Similarly, for example, according toother embodiments of the present invention, one may relax muscles byusing devices according to embodiments of the invention to providetargeted thermal (i.e., heat) therapy via treatment points locatedwithin the rectum. Additionally, for example, devices according toembodiments of the present invention may be utilized to provide targetedpressure therapy, such as trigger point release therapy, internally tothe pelvic region via the vaginal or anal cavities in conjunction withsimultaneous targeted temperature therapy.

Such inflammatory and non-infectious pain syndromes can include pelvicfloor dysfunction (entailing muscles of the pelvic floor, i.e., the areasurrounding the rectum, vagina/scrota, and urethra, not contractingand/or relaxing properly), tension of the pelvic floor muscles (e.g.,spasms of the pelvic floor muscles leading to recurring pelvic pain),painful intercourse or dyspareunia, internal pelvic floor trigger pointsor tender points, vaginismus (spasming of the muscles at the opening ofthe vagina), myofascial pain syndrome (referred pain from trigger pointsin the pelvic area), general vulvodynia, interstitial cystitis (asyndrome that may include suprapubic pain present in the lower abdomen,perineal pain present between the vagina and anus in women or thescrotum and anus in men, pain during sexual intercourse, and painfulejaculation), or chronic pelvic pain (including pressure or heavinessdeep within the pelvis independent of or associated with intercourse,bowel movements, or sitting). Further, such inflammatory andnon-infectious pain syndromes can result from or be related to medicalphysical therapy (e.g., patients may tense prior to therapy expectingdiscomfort or experience inflammation after vaginal or rectal therapy),or sexual activity (e.g., injuries resulting from sexual assault, orgeneral tenderness, soreness and swelling resulting from consensualactivities). Most preferably, the syndromes include pelvic floordysfunction and interstitial cystitis.

Such symptoms associated with or resulting from one or more vaginal oranal/rectal diseases, conditions, or disorders include vaginal or rectalirritation, muscle tightness, burning, inflammation, pain, pressure,muscle spasms, circulation problems, and soreness. Preferably, suchsymptoms can be associated with or resulting from vaginal and/oranal/rectal diseases, conditions, syndromes and disorders includingsexuality complications following cancer treatment (sexual side effectsof cancer treatment can make resuming sex more difficult, especially forwomen being treated for breast or gynecological cancers that cause sideeffects that make sex painful or difficult), side effects andcomplications relating to bladder instillations (patients may tenseprior to the instillation expecting discomfort, or experienceirritation, burning, inflammation and possible flare-up of frequency,pressure and urgency post instillation), sexual complications associatedwith multiple sclerosis (e.g., nerve impulses interruption), irritablebowel syndrome, vaginal atrophy (such as results from decreases inlevels of the female hormone estrogen), non-bacterial prostatitis(inflammation of the prostate can be accompanied by pelvic, groin or lowback pain or urination complications), prostatodynia (e.g., pain in thegenital area, pain with urination, or difficulty urinating), andproctitis (e.g., inflammation of the lining of the rectum called therectal mucosa as side effect of medical treatments like radiationtherapy or antibiotics). Additional vaginal and anal diseases,conditions, syndromes, and disorders the symptoms of which can beaddressed according to the present invention include complications fromvaginal or rectal exams (patients may tense prior to exam expecting painor discomfort, or may experience irritation and inflammation after theexam), postpartum vaginal soreness (such as following resumption ofsexual intercourse) and pain, vaginal and anal exercise and dilation(such as for the treatment of vaginismus and related disorders, andpre-natal perineal message), coccydynia (e.g., inflammation of thetailbone), proctalgia fugax, levator ani syndrome, anorectal pain,anissmus (including anorectal dysfunction that can contribute toconstipation marked by the failure of pelvic floor muscles to relax, ora paradoxical contraction of the pelvic floor muscles with defecation),pelvic floor dyssynergia, pudendal neuralgia, and hemorrhoids.

Devices according to embodiments of the present invention can adopt avariety of configurations that include a generally rod-like body portionhaving two ends, with at least one of the ends having a bulbous tip.Either end of the devices may be used for therapies according to thepresent invention, as needs dictate, to provide targeted pressure and/ortemperature therapy. The devices according to the present invention arethus capable of producing a localized or targeted constant pressure tointernal treatment points during a treatment session while providingtargeted heat (cryogenic or thermal, as desired or appropriate) therapy.

The body portions for such targeted treatment devices can be eitherstraight or bent to facilitate positioning and manipulation of the tipof the inserted end of the device during use. Preferably, the devicesare formed integrally having a generally cylindrical rod-like shape andcircular cross-section shape. The bulbous tip preferably comprises asmooth semi-sphere shape formed on at least one end of the body portion.The semi-spherical shaped tip has a diameter slightly larger then thebody portion of the device.

In most preferred embodiments of the invention, the body portion of thetargeted treatment device has two bends that cause the device to take ona general shape similar to an elongated “S” or lightning boltconfiguration. Such S-shaped configuration makes it easier for patientsto hold the device while achieving various angles of entry anddirections of pressure to self-administer therapy without assistance ofanother person.

Other most preferred embodiments of the present invention areparticularly suitable for delivering cold/warm therapy internally totreatment sites within the vagina and rectum in addition to pressuretherapy. Targeted treatment devices according to embodiments of theinvention are constructed of medically accepted materials that are bothsufficiently strong so as to be safe for applying significant pressure,easy to clean and disinfect/sterilize, and able to easily be heated orchilled to a treatment temperature and retain and transmit that heat orcold to tissue during therapy. In most preferred embodiments of theinvention, the treatment devices are formed of one integral piece ofmedical grade glass, such as Type 1 borosilicate or equivalent medicalglass. Alternative but less preferred materials include stainless steel,silicone, and other analogous materials.

A method according to an aspect of the present invention is directed tothe relief of pelvic region symptoms relating to diseases, disorders,syndromes and conditions of the pelvic region by targeted internaltherapy. The method includes locating one or more intra-rectal orintra-vaginal treatment points within the vaginal or rectal cavity of ahuman subject, with the treatment points being locations of musclespasms, trigger points or sites of symptoms. A handheld device isprovided that includes a body portion having two ends, including a firstend that terminates in a generally bulbous tip. The handheld device isintegrally formed from a nonporous material capable of holdingtemperature and transmitting heat or cold energy to tissue. The deviceis treated to raise or lower the temperature of the device, and then anend of the device is inserted into the subject's rectal or vaginalcavity. The inserted end is thereby brought into contact with one of thetreatment points, and contact is maintained with the treatment point tocause a therapeutic response to occur.

Additionally, a method according to another aspect of the presentinvention is directed to the relief of pelvic region symptoms relatingto interstitial cystitis by targeted internal therapy. The methodincludes locating one or more intra-rectal or intra-vaginal treatmentpoints within the vaginal or rectal cavity of a human subject, with thetreatment points being locations of muscle spasms, trigger points andsites of symptoms. A handheld device is provided that includes a bodyportion having two ends, with a first one of the ends terminating in agenerally bulbous tip. The handheld device is integrally formed from anonporous material capable of holding temperature and transmitting heator cold energy to tissue. The device is treated to raise or lower thetemperature of the device, and then one of the ends of the device isinserted into the subject's rectal or vaginal cavity. The inserted endis thereby brought into contact with one of the treatment points, andcontact is maintained with the treatment point to cause a therapeuticresponse to occur.

Further, a method according to yet another aspect of the presentinvention is directed to the relief of pelvic region symptoms of pain ordiscomfort by targeted internal pressure and temperature therapy. Themethod includes locating one or more intra-rectal or intra-vaginaltreatment points within the vaginal or rectal cavity of a human subject,with the treatment points being locations of muscle spasms, triggerpoints and sites of symptoms. A handheld device is provided thatincludes a body portion having two ends, including a first end thatterminates in a generally spherical bulbous tip. The handheld device isintegrally formed from a nonporous medical grade glass material capableof holding temperature and transmitting heat or cold energy to tissue.The device is treated to raise or lower the temperature of the device,and then an end of the device is inserted into the subject's rectal orvaginal cavity. The inserted end is thereby brought into contact withone of the treatment points and pressure is applied via the handhelddevice. Contact is maintained with the treatment point to cause atherapeutic response to occur.

The various embodiments of the invention having thus been generallydescribed, several illustrative embodiments will hereafter be discussedwith particular reference to several attached drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view drawing depicting a device according to a firstembodiment of the present invention.

FIG. 1B is a perspective view drawing depicting the device according tothe first embodiment of the present invention.

FIG. 2A is a side view drawing depicting a device according to a firstembodiment of the present invention.

FIG. 2B is a top view drawing depicting the device according to thesecond embodiment of the present invention.

FIG. 2C is a perspective view drawing depicting the device according tothe second embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring first to FIG. 1A and FIG. 1B, there is depicted a targetedtherapy device 100 according to a first embodiment of the presentinvention. As shown in the drawings, the device 100 has a generallycylindrical rod-like shape, wherein it has a generally round shape incross-section. The device has a body portion 101 and a first end 102attached to the body portion, which first end 102 terminates in abulbous and rounded tip. Preferably, the tip at the first end is asmooth semi-sphere shape, as depicted. The second end 103 of the device100 preferably terminates in a rounded tip as depicted.

The shape of device 100 as depicted in the drawings is particularlyadvantageous for uses according to the methods of the present inventionfor various reasons. First, the semi-spherical shaped tip at the firstend 102 has a diameter slightly larger then the body portion 101 thatforms a majority of the device 100. This relationship of first end tipdiameter and body portion diameter serves several functions. First, thebulbous tip can be utilized as a handle when the second end 103 of thedevice is used for treatment. Second, the first end 102, meaning thebulbous tip itself, alternatively can be inserted for treatment, thusproviding two unique diameters and tip shapes on a single device fortreatment. Understandably, the smaller of the two ends can be used forcertain treatments (or even initial dilation), while the larger of thetwo ends for others, as each will provide different pressure andtemperature transfer characteristics.

In any event, the tip of the first end 102 or second end 103 can belocated by the patient or physical therapist such that it touches theappropriate treatment site (such as a myofascial trigger point or areaof pain). Also, if desired, lateral pressure can be used on the bodyportion 101 to transfer that pressure predominantly to the treatmentsite.

Referring now to FIG. 2A, FIG. 2B, and FIG. 2C, there is depicted asecond embodiment of a targeted therapy device 200. As shown in thedrawings, the device 200 has a body portion 201 that is formed from agenerally cylindrical rod-like shape that has two bends 201 a and 201 bthat cause the device 200 to take on a shape similar to an “S” orlightning bolt configuration. The body portion 201 of the device isdivided into three sections by the bends 201 a and 201 b, and has afirst end 202 formed on the section terminating the body portion at theend nearest bend 201 b and a second end 203 formed on the sectionterminating the body portion at the end nearest bend 201 a. The firstend 202, similar to device 100, terminates in a bulbous and rounded tip,preferably with the tip taking a smooth semi-sphere shape as depicted.Similarly, the second end 203 of the device 200 terminates in a roundedtip. The entire device 200 generally has round cross section shapes.

The shape of device 200 as depicted in the drawings is particularlyadvantageous for certain uses according to the methods of the presentinvention for various ergonomic reasons. Like with device 100, thesemi-spherical shaped tip at the first end 202 has a diameter slightlylarger then the body portion 201, providing similar advantages fortreatment options and handling characteristics. Bends 201 a and 201 bdifferentiate device 200 from device 100, however, for ease of self-useby certain patients in at-home settings. Understandably, the S-shapedconfiguration obtained will make it easier for patients to hold thedevice 200 while achieving various angles of entry and directions ofpressure to self administer therapy without assistance of anotherperson.

Typically, a device 100 as depicted in FIG. 1A and FIG. 1B will have,for typical uses in adults, a semi-spherical tip that measuresapproximately 27.5 millimeters while the diameter of the body portion101 is approximately 16 millimeters. A suitable device 100 length fromsecond end 103 to first end 102 would be approximately 156 millimeters.This shaft length is preferred as, for average adult females, it issufficiently short to limit the chances of possible injury to the cervixthrough misuse or accident. The diameter of the body portion 101 allowsthe user easier insertion into the sensitive tissue of the vagina and/orrectum for pressure and temperature therapy. For example, the second end103 can be inserted first to relax muscles before the larger diameterfirst end 102 is inserted. These dimensions and relative sizes, ofcourse, can vary while retaining the general qualities of the device100.

The device 200 as depicted in FIG. 2A, FIG. 2B and FIG. 2C will have,for typical uses in adults, a semi-spherical tip that measuresapproximately 27.5 millimeters while the diameter of the body portion101 is approximately 16 millimeters (these dimensions beingsubstantially the same as the corresponding dimensions for device 100).A suitable device 200 length from second end 203 to first end 202(measured “as the crow flies” from tip to tip without following thecurves of the body portion 201) would be approximately 185 millimeters.The angle for the bend 201 b is approximately 100 to 110 degrees whilethe angle for the bend 201 a can be approximately the same, butpreferably with a more gradual bend (e.g., such as occurring overapproximately 60 to 70 millimeters of the body portion 201 length). Theshaft length, diameters and shape of this preferred embodiment of thepresent invention is advantageous because it allows the user tocomfortably self-administer heat/cold therapy and/or apply pressure totrigger or tender points in the vagina or rectum, which would otherwisebe a difficult, if not impossible, task without the help of a therapistor partner.

One skilled in the art will appreciate that the exact shape anddimensions of the particular devices 100 and 200 depicted are notessential to practice of the present invention. However, the designsdepicted are particularly useful and preferred because the smooth designdoes not irritate or damage delicate tissues that line the vaginal orrectal cavities during use and has no sharp or pointy edges orprojections that could invite injury. Further, this design isparticularly preferable for casting of the devices from the most desiredmaterials. However, it should be appreciated that these designs can beinsubstantially altered, such as by, for example, changing thecross-section shape of various portions (the handle or either end) ofthe devices to oval shapes or by providing double bulbous tips with oneon each end of the device (and having, for example, differentdiameters).

In all embodiments of the invention, it is necessary that the materialof construction for the devices be one that is strong so as to be safefor applying significant pressure, easy to clean anddisinfect/sterilize, and able to easily be heated or chilled and retainand transmit that heat or cold during therapy. Further, it is preferredthat the devices be constructed of one integral piece of material topromote strength of the device and to prevent seams or edges fromforming which can cause injury or hamper cleaning anddisinfection/sterilization. Thus, in most preferred embodiments of theinvention, the devices are formed of one integral piece of medical gradeglass. In particular, “Type 1 borosilicate” or equivalent medical glassis preferred as it is non-porous, hypoallergenic, 100% lead-free, formssmooth surfaces to the touch, is strong, and holds and transmits heatand cold very well. Safety of the devices formed from such glass can bereadily tested for safety after manufacture and before use, such as bypolariscope to ensure integrity of the glass. Such medical grade glasshas a proven history of durability in the medical and scientific fieldsand is thereby readily accepted by doctors, physical therapists andother health care providers. Further, Type 1 borosilicate glass beingnon-porous not only makes the devices slick and comfortable during use,but also makes them easy to clean and disinfect/sterilize, and preventsthem from absorbing odors or germs readily (assuming proper cleaningbefore and/or after each use). Thus, medical grade glass provides asignificantly decreased risk of infections in women or men, relative tolatex, rubber, plastic or acrylic. In addition, medical grade glass isdishwasher, refrigerator and microwave oven safe, making devices madeentirely from this material easier to clean and disinfect than devicesmade from other materials.

Alternative but less preferred materials include stainless steel,silicone, and other analogous materials for the formation of the devicesof the present inventions. Additionally, these alternative materials mayor may not be constructed with a frozen gel pack or similar warming orcooling component to be inserted into the product to prolong the warm orcool state.

Medical grade class is also preferred because it is highly capable ofholding and transmitting heat or cold to tissue of a person while beingcapable of maintaining strength and integrity at very high and lowtemperatures. However, for normal purposes, during use the devices maybe chilled to temperatures of approximately 45 degrees Fahrenheit andabove for cryogenic therapy or heated to approximately 105 degreesFahrenheit or below for thermal therapy. As in any type of temperaturetherapy, overuse of hot and cold therapy is not desirable. Medical gradeglass, however, has the added benefit in that they return to bodytemperature within 8 to 10 minutes if heated or chilled within the aboveparameters, thus naturally limiting therapy duration to commonclinically suggested timeframes for temperature therapy. Devices thatuse electrical or chemical means to create temperature gradients in thedevices do not have this built-in treating duration-limiting mechanism.

It should be apparent to one skilled in the art that devices accordingto the present invention can take on various shapes and dimensions, suchas, for example, depicted in the drawings with the straight embodimentand bent embodiment of the present invention, or combinations thereof.Use of alternative materials and product sizes are available to producea unique product that is made for the same uses as that of straightembodiments of the present invention and bent embodiments of the presentinvention.

Direct stimulation of the pelvic floor nerves using devices and methodaccording to the present invention advantageously bypasses otherunrelated nerve groups at the sacral roots. Nerves in this region thatmay be targeted for stimulation include the pudendal nerve, pelvicnerve, and the clitoral branches of the pudendal nerve. The pudendalnerve and its branches are somatic nerves that originate from the sacralnerve roots. These and other somatic nerves emanating from the sacralnerve roots are preferably stimulated to treat dysfunctions of perinealstructures, such as urinary and/or bowel incontinence, urgency,frequency, and/or pain. For instance, stimulation of the urethral branchof the pudendal nerve may be used to inhibit defecation, therebytreating fecal incontinence. Additionally or alternatively, stimulationof the inferior rectal branch of the pudendal nerve, which innervatesthe external anal sphincter, may also inhibit defecation, therebytreating fecal incontinence. Stimulation of other somatic nervesinnervating the rectum and/or colon may treat constipation, fecalretention, and/or colorectal hypomotility. Stimulation of one or moreother pudendal nerve branches (e.g., the dorsal nerve of theclitoris/penis) may be used as a treatment of, e.g., urinary urgeincontinence and/or detrusor hyperreflexia. Stimulation of nervesinnervating the urethra and/or detrusor muscle may treat urinaryretention, while stimulation of nerves innervating the internal and/orexternal urethral sphincter or their intramuscular branches may treaturinary stress incontinence. Stimulation of nerve(s) innervating theclitoris and/or vagina may treat vaginismus, dyspareunia, anorgasmia, orother female sexual dysfunction.

The preferred method of using the devices described herein generallystarts with identifying and locating one or more intra-anal orintra-vaginal treatment points selected from the group consisting oflocations of intra oral muscle spasms, trigger points, nerve clusters,and other points of pelvic floor dysfunction internally within thevaginal or rectal cavity of a human subject. The device according to thepresent invention is then chilled or heated to the desired treatmenttemperature. Optionally, of course, the device could first be used atroom temperature for initial insertion and stretching of the anal orvaginal opening and then chilled or heated to the desired treatmenttemperature.

The particular end of the device chosen for the particular treatment isthen inserted into the anal or vaginal cavity of the patient (usinglubrication as necessary), and the tip of that end is brought intocontact with one of the treatment points. The end of the device is heldin contact with the treatment point (optionally applying mild to firmpressure) until the desired relief response is obtained, such as atrigger point release, pain relief, discomfort relief, inflammationabating, etc. Therapy can then continue to additional treatment points.

Optionally, manual pressure is applied to the extent that the user cantolerate, sometimes relaxing and then periodically reapplying thepressure to cause a particular trigger point to release or to causesensations of pain or discomfort to abate and thereby eliminate orminimize the pelvic area symptom that was previously experienced by thepatient. Similarly, hot and cold therapy can be used in alternatingfashion.

For example, to locate treatment points, such as muscle tissue wheretrigger points are found, a patient or physical therapist can use thedevice in a trial and error manner, moving the inserted end internallyto locate areas of pain or trigger points. The device is shiftedupwardly, downwardly or sideways and manual pressure can be applied tofind tender or trigger points or other areas of localized pain,discomfort, or undesired symptoms. Similarly, treatment points can beselected by physicians or physical therapists based upon generaldiagnoses (such as instructing male patients to apply cold therapytargeted near the front wall of the rectum when cases of non-bacterialprostatitis are diagnosed).

As will be readily appreciated by one skilled in the art, an advantageof the invention is its portability and that the patient can utilizethis invention whenever tissue pain or other symptoms arise. The devicesaccording to the invention are easily heated or cooled by a variety ofmeans commonly available both in the home and while traveling, includinghot or cold water, ice, refrigerators, and microwave ovens. No longer isthe patient's treatment schedule dependent on the time slot available tohim or her in the physical therapist's office to alleviate the pain.

Therefore, as described above, straight embodiments of the presentinvention or bent embodiments of the present invention both provide allthe benefits of cold/warm therapy to help relieve pain and relax musclesin the vagina and rectum to resolve various symptoms, including pain,inflammation, swelling, burning and stress/tension. They can be reusedagain and again, unlike chemical hot or cold packs, and with littleexpense.

Particular examples of suitable uses of the devices of the presentinvention according to the methods herein disclosed include thefollowing. For chronic tightness of the pelvic floor, but not an acuteexacerbation, warmed devices of the present invention can be insertedfor 5 to 10 minutes at a time 2-3 times per day. For an acute flare-upof tightness of the pelvic floor of a normally “under control”condition, chilled devices of the present invention can be inserted for5 to 10 minutes 2-3 times per day. Additionally, for pain during orafter intercourse, devices according to the present invention may beinserted warm prior to intercourse for 5 minutes to relax pelvic floormuscles. Then, after intercourse, a device can be inserted cold for 5-10minutes (two devices may be needed). The cold treatment can be repeatedan hour or two later if necessary.

Similarly, for treatment of chronic low level pelvic pain, devices canbe used warm for 5 minutes to relax pelvic floor muscles and 3 minutescold to reduce inflammation—alternating 3 to 5 times and ending with acold session. This can be repeated once or twice daily. (Again, twodevices may be needed). For episodes of severe pain, the device can bein either the warm or cold state (whichever works best for the patient)not to exceed 10 minutes per hour.

For release of tight trigger point muscles in the vagina or rectum, thedevice can be used warmed to simultaneously apply gentle pressure toeach trigger point for 30-90 seconds. If the trigger point does notimmediately release, the warming therapy could be delivered (withoutapplying significant pressure), and then pressure therapy later retried.

With these generalized potential situations for using variousembodiments of the invention being thus described, several examples willnow be provided to support the benefits of the present invention.

Example 1

A physical therapist reported being referred from a doctor a patientwith a diagnosis of levator ani syndrome (chronic tension of the levatormuscle, sometimes stress derived) and associated constipation. Thepatient was an age 74 woman that reported having symptoms of severe painin her rectum and vagina after a bowel movement on a daily basis, whichsymptoms had been present for 6 years. Treatment with variousmedications had been tried over that time period without resulting inrelief. She sought medical care from a gastrointestinal physician andwas referred to physical therapy for the treatment of her pelvic floordysfunction.

On initial assessment patient reported her pain averaged an “8” on thecommon 10-point pain scale, and that she was having extreme difficultyinitiating a bowel movement. On objective examination, the patient wasnoted to have severe muscle guarding in her puborectalis, pubovaginalisand iliococcygeus musculature bilaterally. The patient was instructed inmanual myofascial stretching techniques and was recommended to use adevice according to embodiments of the invention (in particular, a bentembodiment similar to device 200 described above) forself-administration of trigger point release within the vagina andrectum. The patient was able to administer targeted treatmentindependently with the device vaginally, and found it gave her goodrelief of her pain symptoms. Patient also reported placing the device(made of borosilicate glass) in the refrigerator to utilize cryotherapyin addition to the manual pressure techniques and found that this helpedthe most with relieving her pain symptoms.

After 4 weeks of using the device according to the prescribed methodwith cryotherapy, the patient was able to independently self-manage herpain symptoms. Her average pain had decreased to 1-2 on the 10 pointscale, and she reported no longer was having difficulty initiating abowel movement. The patient also reported that the device was easy touse and very effective in reducing her pain complaints.

Example 2

A female patient, age 48, suffered from interstitial cystitis for aperiod of years. Following other unsuccessful treatments, the patientwas referred to a physical therapist to obtain vaginal trigger pointrelease treatments for pelvic floor dysfunction. The patient reportedthat internal trigger point release was helpful, but that severe painwould be experienced after and between treatment sessions.

The therapist then suggested that the patient try targeted pressure andcryogenic therapy using a treatment device according to the embodimentsof FIGS. 1 a-1 c to alleviate pain following and between therapysessions. The patient reported significant pain relief using the devicevaginally 5-10 minutes as needed after first chilling the device in arefrigerator.

Example 3

An adult female patient presented with chronic pain in the pelvic regionassociated with her diagnosed disease Interstitial Cystitis. She had thedisease for approximately 8 years and had tried but not experiencedsuccess with various medications to manage her pain symptoms. Patientwas instructed in the use of a targeted pressure and temperaturetreatment device according to the embodiments of the invention andutilized the device for both thermal and cryogenic therapy vaginally.The patient reported benefits from using the device either heated orcold with a preference for cold. The patient reported that herthen-current pain symptoms were lessened following each use by at least3 points on a pain scale of 1 to 10.

Example 4

An age 38 male patient suffering from pelvic floor dysfunction due tosymptoms associated with chronic pelvic pain syndrome reported pain andspasms associated with ejaculation. In conjunction with the advice of aphysical therapist, the patient began to use embodiments of devices ofthe present invention to perform temperature therapy prior tointercourse. In particular, the patient used a device warmed above bodytemperature prior to intercourse in conjunction with his normal physicaltherapy routine to help relax his pelvic floor muscles. The patientreported significant improvement in symptoms.

Example 5

An adult woman diagnosed with vulvodynia, vulvar vestibulitis, andtrigger and tender points began using devices according to the presentinvention upon the recommendation of her gynecologist and physicaltherapist. The patient reported having struggled with pain andirritation associated with these diagnosed conditions for a period ofover 7 years.

The patient was instructed by the gynecologist to perform cryogenictherapy according to embodiments of the present invention to alleviatesymptoms of pain and irritation due to vulvar vestibulitis. Inconjunction with the physical therapist, the patient also began toperform self-administered thermal therapy according to embodiments ofthe invention prior to physical therapy sessions to help relax herpelvic floor muscles, and also used devices according to the presentinvention to self-administer trigger point release pressure therapy athome.

The patient reported that the cryogenic therapy alleviated her painsignificantly and that the thermal and pressure therapy helped her relaxher pelvic floor muscles prior to intercourse and during trigger pointpressure therapy.

Having described preferred embodiments of the invention it will nowbecome apparent to those of ordinary skill in the art that otherembodiments incorporating these concepts may be used. Accordingly, it issubmitted that the invention should not be limited to the describedembodiments but rather should be limited only by the spirit and scope ofthe appended claims. Although the invention has been described andillustrated with a certain degree of particularity, it is understoodthat the present disclosure has been made only by way of example, andthat numerous changes in the combination and arrangement of steps ororientation of parts can be resorted to by those skilled in the artwithout departing from the spirit and scope of the invention, ashereinafter claimed.

1. A method for the relief of pelvic region symptoms relating todiseases, disorders, syndromes and conditions of the pelvic region bytargeted internal therapy, said method comprising the steps of: locatingone or more intra-rectal or intra-vaginal treatment points within thevaginal or rectal cavity of a human subject, said treatment points beingselected from the group consisting of locations of muscle spasms,trigger points and sites of said symptoms; providing a handheld devicecomprising a body portion having first and second ends, said handhelddevice being integrally formed from a nonporous material capable ofholding temperature and transmitting heat or cold energy to tissue, oneof said device ends terminating in a generally bulbous tip; treatingsaid device to raise or lower the temperature of the device; insertingsaid first end into the subject's rectal or vaginal cavity and therebybringing the inserted first end into contact with one of the treatmentpoints; maintaining contact with the treatment point to cause atherapeutic response to occur; and applying pressure to said treatmentpoint in contact with said inserted first end by manually assertinglateral pressure near said second end, wherein said body portion issized and configured to permit, while said first end is maintained incontact with said treatment point, said second end to extend out of thecavity of the subject a sufficient amount to enable said subject tograsp said body portion and manipulate said device to transfer lateralpressure to said treatment point.
 2. The method according to claim 1,wherein said generally bulbous tip has a diameter greater than adiameter of said body portion.
 3. The method according to claim 2,wherein said generally bulbous tip comprises a semi-sphere.
 4. Themethod according to claim 1, wherein said therapeutic response includesa trigger point release response, a pain relief occurs, a discomfortrelief response, or an inflammation abating response.
 5. The methodaccording to claim 1, wherein said applying of pressure comprisesdelivering pressure at said treatment site at or below a moderatediscomfort level for the patient, wherein said moderate discomfort levelis defined as below a point at which the patient winces or tensesinvoluntarily.
 6. The method according to claim 1, wherein the applyingpressure step is performed for approximately 30 seconds to approximately90 seconds.
 7. The method according to claim 1, wherein the reliefresponse comprises softening of the treatment point.
 8. The methodaccording to claim 1, wherein the applying pressure step comprisesmanipulating said second end to apply pressure via said first end at aplurality of dissimilar angles to the treatment point.
 9. The methodaccording to claim 1, further comprising: repositioning the handhelddevice; bringing the inserted first end into contact with another of thetreatment points; and maintaining contact with said another treatmentpoint to cause a therapeutic response to occur.
 10. The method accordingto claim 1, wherein said device is used internally for approximately8-10 minutes.
 11. The method according to claim 1, wherein said deviceis used internally until it returns to room or body temperature.
 12. Themethod according to claim 1, wherein said treating of said devicecomprises heating the device to a temperature above body temperature andbelow approximately 105° F.
 13. The method according to claim 1, whereinsaid treating of said device comprises cooling the device to atemperature above approximately 45° F.
 14. The method according to claim1, wherein the bulbous tip of the handheld device has a diameter that isapproximately 1.5 to 2 times the diameter of said body portion.
 15. Themethod according to claim 14, wherein the bulbous tip of the handhelddevice has a diameter of approximately 27.5 mm.
 16. The method accordingto claim 1, wherein the body portion of the handheld device has at leasttwo bends such that said device adopts an S-shaped or lightning boltshape in profile.
 17. The method according to claim 1, wherein thehandheld device is integrally formed from medical grade glass.
 18. Themethod according to claim 17, wherein said medical grade glass is Type 1borosilicate.
 19. The method according to claim 1, wherein said symptomsare selected from the group consisting of pain, discomfort, soreness,weakness, inflammation, pressure, muscle spasms, itching, burning andirritation.
 20. The method according to claim 1, wherein said patienthas been diagnosed with an inflammatory, non-infectious pain syndromeselected from the group consisting of pelvic floor dysfunction,dyspareunia, vaginismus, non-bacterial prostatitis, vulvodynia andinterstitial cystitis.
 21. A method for the relief of pelvic regionsymptoms relating to interstitial cystitis by targeted internal therapy,said method comprising the steps of: identifying a human subject ashaving interstitial cystitis; locating one or more intra-rectal orintra-vaginal treatment points within the vaginal or rectal cavity ofthe human subject, said treatment points being selected from the groupconsisting of locations of muscle spasms, trigger points and sites ofsaid symptoms; providing a handheld device comprising a body portionhaving first and second ends, said handheld device being integrallyformed from a nonporous material capable of holding temperature andtransmitting heat or cold energy to tissue; treating said device toraise or lower the temperature of the device; inserting said first endinto the subject's rectal or vaginal cavity and thereby bringing theinserted first end into contact with one of the treatment points; andmaintaining contact with the treatment point to cause a therapeuticresponse to occur, wherein said body portion is sized and configured topermit, while said first end is maintained in contact with saidtreatment point, said second end to extend out of the cavity of thesubject a sufficient amount to enable said subject to grasp said bodyportion and manipulate said device to transfer lateral pressure to saidtreatment point.
 22. The method according to claim 21, wherein thehandheld device is integrally formed from medical grade glass.
 23. Themethod according to claim 22, wherein said medical grade glass is Type 1borosilicate.
 24. The method according to claim 21, wherein at least oneof said ends terminates in a generally bulbous tip that has a diametergreater than a diameter of said body portion.
 25. The method accordingto claim 24, wherein said generally bulbous tip comprises a semi-sphere.26. The method according to claim 24, wherein the bulbous tip of thehandheld device has a diameter that is approximately 1.5 to 2 times thediameter of said body portion.
 27. The method according to claim 24,wherein the bulbous tip of the handheld device has a diameter ofapproximately 27.5 mm.
 28. The method according to claim 21, wherein thebody portion of the handheld device has at least two bends such thatsaid device adopts an S-shaped or lightning bolt shape in profile. 29.The method according to claim 21, wherein said symptoms are selectedfrom the group consisting of pain, discomfort, soreness, weakness,inflammation, pressure, muscle spasms, itching, burning and irritation.30. A method for the relief of pelvic region symptoms of pain ordiscomfort by targeted internal pressure and temperature therapy, saidmethod comprising the steps of: locating one or more intra-rectal orintra-vaginal treatment points within the vaginal or rectal cavity of ahuman subject, said treatment points being selected from the groupconsisting of locations of muscle spasms, trigger points and sites ofsaid symptoms; providing a handheld device comprising a body portionhaving first and second ends, said handheld device being integrallyformed from a nonporous material capable of holding temperature andtransmitting heat or cold energy to tissue, one end of said device endsterminating in a substantially spherical bulbous tip; treating saiddevice to raise or lower the temperature of the device; inserting saidfirst end into the subject's rectal or vaginal cavity and therebybringing the inserted first end into contact with one of the treatmentpoints; applying pressure at said treatment point via said handhelddevice; and maintaining contact with the treatment point to cause atherapeutic response to occur, wherein said first and second ends ofsaid handheld device are both sized and configured to be insertable intothe subject's rectal or vaginal cavity and thereby brought into contactwith one of the treatment points.
 31. The method according to claim 30,wherein said non-porous material is Type 1 borosilicate.
 32. The methodaccording to claim 30, wherein said handheld device is substantiallyshaped like a rod or a bent rod whereby, while said first end is incontact with said treatment point, said body portion proximate saidsecond end extends out of said cavity and may be grasped by saidsubject.
 33. The method according to claim 32, further comprisingmanipulating said second end to apply lateral pressure at the treatmentpoint via said first end.
 34. The method according to claim 30, furthercomprising: extracting the first end of the handheld device from therectal or vaginal cavity; inserting said second end into the subject'srectal or vaginal cavity and thereby bringing the inserted second endinto contact with one of the treatment points; applying pressure at saidone of the treatment points via said handheld device; and maintainingcontact with the treatment point to cause a therapeutic response tooccur.
 35. The method according to claim 34, wherein said second endterminates in a substantially spherical bulbous tip.